Regulatory

The I3 offers assistance to help you navigate the regulatory requirements and alphabet soup involved in any clinical development. We understand that many research groups may not have experience with clinical trials and are ready to tailor our input to you. Most importantly, we are equipped to help you in the development of new molecular entities and devices.

Here are some of the aspects of regulation that we are ready to help you with:

  • Interaction with regulatory authorities: Our experience allows us to effectively communicate with the FDA, IRBs, and RDRC because we know what they expect.
  • GMP, GLP, and CMC: We can help you train and prepare for the regulations to ensure the highest safety standards for your human research.
  • Document drafting: INDs, IDEs, IRBs? We can help you understand, write, organize, and submit the proper documents to regulatory agencies and walk you through the approval process.
  • Project management: While your group works in the lab, our administrative staff can assist on an as-needed basis to help you orchestrate the regulatory aspects of your trials.

The challenges of development are daunting, requiring a careful balance of minimizing costs while meeting standards; we will help you make vital decisions to ensure compliance.